A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome

NCT00436033 ↗

Phase 3 Completed 1429 enrolled Pierre Fabre Laboratories

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

Timeline

Start: 2006-02
Primary completion: 2007-09
Completion: 2007-09

Outcome

Met primary endpoint

paper milnacipran 200 mg/day showed significant improvements from baseline relative to placebo in the 2-measure composite responder criteria (p = 0.0003) PMID 20156949 ↗

paper and FIQ total score (p = 0.015). PMID 20156949 ↗

Publications

Branco JC, Zachrisson O, Perrot S, Mainguy Y; Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol. 2010 Apr;37(4):851-9. doi: 10.3899/jrheum.090884. Epub 2010 Feb 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Milnacipran	Other / unclassified	200 mg	—